Gallium Ga 68-labeled PSMA-11 PET/CT or PET/MRI in Diagnosing Patients with Intermediate to High-Risk Prostate Cancer

Status: complete

This phase I/II trial studies how well gallium Ga 68-labeled PSMA-11 positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI) work in diagnosing patients with intermediate to high-risk prostate cancer. Gallium Ga 68-labeled PSMA-11 is an imaging drug that binds to prostate tumor cells and can be imaged using PET. Diagnostic procedures, such as gallium Ga 68-labeled PSMA-11 PET/CT and PET/MRI, may help find the presence of prostate cancer that has spread to other parts of the body.

Inclusion Criteria

Biopsy proven prostate adenocarcinoma
Planned prostatectomy with lymph node dissection
Intermediate to high-risk disease (as determined by elevated PSA [PSA > 10], T-stage [T2b or greater], Gleason score [Gleason score > 6] or other risk factors)
Diagnostic CT or MRI as part of the PET study or performed within one month of PSMA PET
Karnofsky performance status of >= 50 (or Eastern Cooperative Oncology Group [ECOG]/World Health Organization [WHO] equivalent)
Ability to understand a written informed consent document, and the willingness to sign it

Exclusion Criteria

Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam
Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy * Including focal ablation techniques (high-intensity focused ultrasound therapy [HiFu])
Androgen deprivation therapy or other neoadjuvant treatments prior to PET imaging and surgery
Contraindication to Lasix

PRIMARY OBJECTIVES:

I. Sensitivity, specificity, positive and negative predictive value of prostate-specific membrane antigen (PSMA) PET for the detection of regional nodal metastases compared to pathology at radical prostatectomy on a per patient basis.

II. Sensitivity, specificity, positive and negative predictive value of PSMA PET for the detection of regional nodal metastases compared to pathology at radical prostatectomy on a per patient basis using nodal regional correlation.

SECONDARY OBJECTIVES:

I. Sensitivity, specificity, positive and negative predictive value of PSMA PET for the detection of extra-pelvic nodal metastases, visceral metastases and osseous metastases compared to biopsy and imaging follow-up.

II. Safety.

TERTIARY OBJECTIVES:

I. Sensitivity, specificity, negative and positive predictive value for detection of regional nodal metastases in comparison to cross sectional imaging performed contemporaneously with the PSMA-11 PET.

II. One year prostate-specific antigen (PSA) progression free survival, comparing patients with and without pelvic nodal metastases.

III. Correlation between SUVmax from PSMA-11 PET and short axis diameter of nodal disease on cross sectional imaging correlate to presence of true pathology.

IV. Incidence of osseous and distant metastatic lesions.

OUTLINE:

Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV) over 1-2 minutes. Beginning 50-100 minutes later, patients undergo PET/CT over 30-40 minutes or PET/MRI over 50-60 minutes.

After completion of study, patients are followed up for 1 day.

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Gallium Ga 68-labeled PSMA-11 PET/CT or PET/MRI in Diagnosing Patients with Intermediate to High-Risk Prostate Cancer

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